FDA clarifies informed consent provisions in COVID-19 clinical guidance
The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to clarify how sponsors can obtain informed consent from patients in isolation or who can receive electronic copies of informed consent documents but due to time constraints cannot print or electronically sign the documents.The guidance, which has been updated frequently as more questions arise from sponsors during the pandemic, is intended to help sponsors protect patients and mitigate the effects of COVID-19 on their studies. FDA also recently issued a guidance offering statistical recommendations for trials impacted by COVID-19. (RELATED: FDA updates COVID-19 clinical trials guidance to address serious adverse events, Regulatory Focus 18 May 2020; E-signatures clarified in FDA’s COVID-19 clinical trial guidance, Regulatory Focus 4 June 2020; FDA offers statistical guidance for trials impacted by COVID-19, Regulatory Focus 17 June 2020).
In this latest update, FDA revised two existing questions and answers, one on obtaining informed consent from patients in isolation and one on documenting details when using videoconferencing in lieu of trial visits.
For hospitalized patients who are in isolation when the hospital’s infection control policy prevents trial staff from entering the patient’s room to collect a signed informed consent form, FDA breaks down its recommendations into two methods.
In the first method, the unsigned consent form is provided to the patient and reviewed via phone or videoconference. After receiving verbal confirmation by the patient, a photograph of the signed consent form can be sent to the investigator or designee and entered into the trial records.
The second method details how sponsors can obtain informed consent when a witness can attest to a signature, but it is not possible to send a photograph of the signed consent form as in method one.
In a newly added question, FDA explains how informed consent can be obtained and documented from prospective trial participants in situations where they or their legal representative cannot print and sign a paper copy of the consent form, cannot electronically sign a consent form and where it would not be feasible to provide a paper copy of the consent form via mail or courier.
In such circumstances, FDA describes a seven-step processes for obtaining informed consent that involves reviewing the informed consent document by phone or teleconference and having the participant or their representative sign and date a blank piece of paper with a written statement affirming that they agree to participate in the trial.
“After signing and dating the newly created document, the trial participant (or legally authorized representative) sends a photograph of the signed and dated statement by facsimile, text message, or email to the investigator/designee; OR returns the document to the investigator by mail at a later date, or at a future study visit that might occur in person,” FDA writes.
When videoconferencing is used for trial visits, FDA clarifies its expectations for what should be documented in the trial records, noting that the date of a real-time video conference visit should be documented, as well as the time of the visit if specified in the protocol. FDA also explains that, “Investigators should consider asking for the trial participant’s location during a video conference visit in case a medical emergency arises during the visit.”